Pilot Study of a Brain Health Program in Senior Centers

Massachusetts General Hospital60 enrolled

Overview

The investigators will evaluate a brain health programs in older adults with subjective cognitive decline. The primary aim of the study is to determine the credibility, expectancy, feasibility, acceptability, appropriateness, fidelity, and satisfaction of the program delivered in the senior centers.

The investigators aim to promote brain health by reducing lifestyle risk factors for dementia in older adults with subjective cognitive decline (SCD). This study is a pilot trial of a mindfulness-based lifestyle programs. Eligible older adults include: age ≥ 50, self-reported worry about changes in memory or thinking, and self-reported interest in improving lifestyle behaviors. Participants complete 8 weekly 90-minute sessions delivered by a clinical psychologist or trainee. All participants will wear an activity watch to support and monitor lifestyle changes during the program. Each session will focus on a different topic relevant to brain health (e.g. physical activity, sleep, etc.). The primary aim of the study is to determine the credibility, expectancy, feasibility, acceptability, appropriateness, fidelity, and satisfaction of the program, delivered in senior centers.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Memory Loss (Excluding Dementia)Lifestyle (Sedentary Behavior and Physical Activity)

Interventions

My Healthy BrainBEHAVIORAL

My Healthy Brain is an 8-week group program delivered via 90-minute meetings led by a clinical psychologist pr trainee. It provides education on the link between dementia and lifestyle factors, including poor exercise, sleep, diet/nutrition, mental and social stimulation, alcohol, and smoking. My Healthy Brain participants learn evidence-based mindfulness and behavior change skills to address common barriers to healthy habits, such as stress and setting achievable goals. My Healthy Brain participants wear an activity watch to monitor lifestyle changes during the program.

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Aged ≥ 50 * Subjective cognitive decline (SCD; e.g., forgetting information, getting lost, and repeating oneself) * Able to self-identify at least 1 modifiable lifestyle risk factors for dementia to change during the program (physically inactive, poor sleep, non-adherence to Mediterranean diet, alcohol use, tobacco use, socially isolated or lonely, mental inactivity) * Absence of significant cognitive impairment (assessed using Short Blessed Test71 ≤ 9) * Self-reported English proficiency/literacy * Ability and willingness to participate and complete all study-related activities Exclusion Criteria: * Dementia or other neurodegenerative disease per patient self-report or disclosure * Psychosis, uncontrolled schizophrenia or schizoaffective disorder, uncontrolled bipolar disorder, or uncontrolled substance dependence/abuse * Active self-report of suicidal ideation / high risk of suicide * Serious medical illness expected to worsen during the study * Self-reported safety issues with initiating lifestyle change

Outcomes

Primary Outcomes

Rates of Treatment Completion

We will assess the acceptability of treatment by calculating the proportion of participants who attend ≥ 6/8 treatment sessions (≥ 70% good, ≥ 80% excellent).

Time frame: 8 Weeks

Client Satisfaction Questionnaire

Assesses patient satisfaction with the program. Higher total scores (min = 3, max = 12) indicate greater satisfaction (≥ 70% good, ≥ 80% excellent)

Time frame: 8 Weeks

Secondary Outcomes

Credibility and Expectancy Questionnaire

Assesses how believable, convincing, and logical patients perceive the treatment to be. Higher scores (min = 3, max = 27) scores indicate greater credibility and expectancy (≥70% good, ≥ 80% excellent)

Time frame: 0 Weeks

Rates of Recruitment

We will assess the feasibility of recruiting and enrolling participants into the study by calculating the proportion who agree to screen divided by the total number contacted (≥70% good, ≥ 80% excellent).

Time frame: 0 Weeks

Rate of Enrollment

Proportion of participants who agree to enroll from the total deemed eligible to participate (≥70% good, ≥ 80% excellent)

Time frame: 0 Weeks

Rates of Valid Activity Watch Data (10 or more hours of wear time)

We will assess the feasibility of collecting valid activity watch data by calculating the proportion of participants who wore the watch at least 5 out of 7 days per week for at least 10 or more hours per day, divided by the total number of days in the program (≥ 70% good, ≥ 80% excellent).

Time frame: 8 Weeks

Rates of Missing Outcomes Data

We will assess the feasibility of data collection by calculating the proportion of secondary outcomes (cognition and lifestyle) with no missing data divided by the total number collected (≥70% good, ≥ 80% excellent).

Time frame: 8 Weeks

Rates of Staff Fidelity to Study Procedures

We will collect and report the number of protocol deviations.

Time frame: 8 Weeks

Rate of Adverse Events

We will collect and report participant's self-reported adverse events.

Time frame: 8 Weeks

Modified Patient Global Impression of Change

The proportion of participants who report perceived improvements in cognitive function, lifestyle, and emotional well-being outcomes (1=Very Much Worse, 7=Very Much Improved).

Time frame: 8 Weeks

Pilot Study of a Brain Health Program in Senior Centers

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts